Zydus Cadila’s ZyCoV-D vaccine receives approval; first jab for children over the age of 12 in India

Zydus Cadila’s ZyCoV-D plasmid DNA vaccine against Covid has received regulatory approval. The Drugs Controller General of India has granted approval to the Ahmedabad-based pharmaceutical company (DCGI).

“The Zydus Cadila has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today, i.e. 20/08/2021, the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 to be administered in humans including adults,” according to a press release from the Department of Biotechnology under the Ministry of Science and Technology.

The vaccine was developed in collaboration with the Department of Biotechnology, Government of India, and is being implemented by the Biotechnology Industry Research Assistance Council (BIRAC). ZyCoV-D has been supported under COVID-19 Research Consortia through the National Biopharma Mission for pre-clinical studies, Phase I and Phase II clinical trials, and under the ‘Mission COVID Suraksha’. “ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for preclinical studies, Phase I and Phase II clinical trials, and Mission COVID Suraksha for Phase III clinical trials,” the statement said.

“This three-dose vaccine, when injected, produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which is critical for disease protection and viral clearance. The plasmid DNA platform’s plug-and-play technology can be easily adapted to deal with virus mutations, such as those that are already occurring “According to the statement.

“It is a matter of great pride that today we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D by Zydus developed in collaboration with the Department of Biotechnology and supported through Mission COVID Suraksha,” said Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC. The Indian Vaccine Mission COVID Suraksha, launched as part of BIRAC’s Atma Nirbhar Bharat package 3.0, aims to develop safe and effective COVID-19 vaccines for public health. We are confident that this vaccine will be beneficial to both India and the rest of the world. This is a significant milestone in our Indigenous Vaccine Development Mission, and it places India on the global stage.This is a significant step forward in our Indigenous Vaccine Development Mission, putting India on the map for novel vaccine development.”

Pankaj R Patel, Chairperson of the Zydus Group, commented on the development, saying, “We are overjoyed that our efforts to develop a safe, well-tolerated, and effective vaccine to combat COVID-19 have resulted in ZyCoV-D. Creating the world’s first DNA vaccine at such a critical juncture, despite all the challenges, is a testament to Indian research scientists and their innovative spirit. I’d like to thank the Government of India’s Department of Biotechnology for their assistance with the Atma Nirbhar Bharat and Indian Vaccine Mission COVID Suraksha missions.”

During the Rajya Sabha’s question hour during the monsoon session, Union Health Minister Mansukh Mandaviya stated, “The government anticipates that four more Indian pharmaceutical companies will begin production of indigenous vaccines in October-November, helping to meet domestic demand. Biological E and Novartis vaccines will also be available in the coming days, and Zydus Cadila will soon be approved for emergency use by the Expert Committee.”

Zydus Cadila announced last month that it had applied to the Indian Drug regulator for an emergency use authorization for its three-dose COVID-19 vaccine ZyCoV-d, and that it planned to manufacture 10-12 crore doses per year.

In over 50 centres, the company has conducted the largest clinical trials for its COVID-19 vaccine in India to date.

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